Heat and Moisture Oxygen Port Changes Classification

F

Fredde

#1
Sometimes ;) the QSR causes headache in it?s lack of clarity.
I have a device, a "heat and moisture"-exchanger which in Europe/Canada is class 1 and also in US with the classification code BYD.

It is a device used on a stoma by a spontaniously breathing patient in order to capture the heat and moisture from the exhaled air and return it to the inhaled air. No rocket science there.

However; we now intend to introduce a variant that have an oxygen port. In both Europe and Canada it is now a class II because it is connected to an active medical device.

But what about US?? Can?t find anything.

Anyone who give a hint or can point me to a regulation I can reference for a decision?

Thanks.
 
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M

MIREGMGR

#2
As far as I can tell, BYD is the only Product Code associated with 21CFR 868.5375.

Is there a competing product already marketed in USA with the oxygen port functionality? Does that maker hold a 510(k) for that product?

Given the first point above, I don't see any basis for determining that the functionality change you describe will change the classification, because there's no other place to put the device and (my perspective) the difference or change is not sufficiently substantial risk-wise that the device would require De Novo or a Product Code creation process.

If per the second point, the answer to the first question is yes and to the second question is no, I'd say that you're on safe ground. You could cite that comparable "precedent" to in a memo-to-file support your decision.
 
F

Fredde

#3
Thanks for the response. Very helpfull.
There are older 510(k)s when products were not exempted but no newer ones. Most manufacturers have kept original names on their products so addition of a new version or oxygen port can not be determined by reading the old 510(k). They often lack summary so no info there either.
 
A

Adele

#4
I agree with MIREGMGR.

Additionally, you can refer to the last centence in the 21 CFR 868.5375. It states "The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9". You can document that the addition of the oxygen port still means your device is a Class I as per 21 CFR 868.5375 as it doesn't make your device fall into any of these categories which would prompt a 510(k):
(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device;
(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; or
(c) The device is an in vitro device that is intended to . . . . . .
 
F

Fredde

#5
That?s sounds like a sensible idea. Allways good to document the basis of the decision. Thanks.

:thanx:
 
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